Thank you for your inquiry to the Occupational Safety and Health
Administration's (OSHA's) Directorate of Enforcement
Programs (DEP). This letter constitutes OSHA's interpretation
only of the requirements discussed and may not be applicable to
any scenarios not delineated within your original inquiry. You
had specific questions regarding the administration of a new
drug, Forteo®, and its applicability to OSHA's bloodborne
pathogens standard, 29 CFR 1910.1030. Your question is restated
below followed by OSHA's response.

Scenario: The FDA has recently approved a new
osteoporosis drug, Forteo®, which is being prescribed for use
in long term care facilities. The drug is currently only
available in a pen-type syringe, which is attached to an
unprotected needle prior to administration. This pre-filled pen
contains multiple doses and may be administered for up to 28 days
after the first injection. As there is currently no other way a
patient may be injected with Forteo®, the practice in long
term care facilities is to remove the used needle after
administration of this drug, either by recapping and removing the
needle manually, or by using a sharps container equipped with a
mechanical unwinding device. The pre-filled pen is then recapped
and refrigerated for future use.

Question: How does this current practice affect a
facility's compliance with the requirements of OSHA's
bloodborne pathogens standard?

Reply: OSHA's bloodborne pathogens standard prohibits
the bending, recapping or removal of a contaminated needle or
other contaminated sharp [29 CFR 1910.1030(d)(2)(vii)(A)]. The
standard also provides an exception where an "employer
can demonstrate that no alternative is feasible or that such
action is required by a specific medical or dental procedure.
Such bending, recapping or needle removal must be accomplished
through the use of a mechanical device or a one-handed
technique" [29 CFR 1910.1030(d)(2)(vii)(B)]. The
preamble to the bloodborne pathogens standard notes that the
administration of incremental doses of a medication is one
medical procedure, among others, to which this exception refers
[56 FR 64118 (1991)].

In the scenario you described, patients are required to be
injected with medication that is not commercially available in a
device with a safety engineered sharp injury protection (SESIP)
system. Also, as we understand, the drug itself is not available
in any other format, meaning Forteo® is not presently
available from the manufacturer in a liquid format which could be
drawn (like other drugs/medications) from a vial into a safety
engineered (SESIP) syringe. OSHA interprets this to mean that under special circumstances
where, for example, "SESIP" use is not technically
feasible and the medical procedure requires the removal of a
contaminated sharp, the use of a mechanical device (e.g., sharps
container with an unwinder) would be allowed. Thus, under these
circumstances, the needle used to administer Forteo® may be
removed by a mechanical device, such as a sharps container with
an unwinder, or a one-handed technique. An explanation for the
medical need for needle removal must be documented in the
employer's Exposure Control Plan [29 CFR
1910.1030(d)(1)(ii)(B)].

In order to limit the practice of removing contaminated needles
and lessen the likelihood of employees suffering needlestick
injuries, employers must train employees on the purpose of the
mechanical needle removal device and ensure that it is only
available for use in extreme circumstances like the use with the
Forteo® Pen [29 CFR 1910.1030(g)(2)(vii)(F)]. Each employer is
responsible for ensuring that employees do not utilize needle
removal procedures for situations where other methods of disposal
are feasible or where SESIPs are commercially available and
appropriate for use.

Thank you for your interest in occupational safety and health.
We hope you find this information helpful. OSHA requirements are
set by statute, standards, and regulations. Our interpretation
letters explain these requirements and how they apply to
particular circumstances, but they cannot create additional
employer obligations. This letter constitutes OSHA's
interpretation of the requirements discussed. Note that our
enforcement guidance may be affected by changes to OSHA rules.
Also, from time to time we update our guidance in response to new
information. To keep apprised of such developments, you can
consult OSHA's website athttp://www.osha.gov. If you have any further questions, please feel
free to contact the Office of Health Enforcement at
202-693-2190.

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